The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Ortho-cms.
| Device ID | K041162 |
| 510k Number | K041162 |
| Device Name: | ORTHO-CMS |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, B.V. Schuttersveld 9 Leiden, NL 2316 Xg |
| Contact | J.i. Hollander |
| Correspondent | J.i. Hollander MEDIS MEDICAL IMAGING SYSTEMS, B.V. Schuttersveld 9 Leiden, NL 2316 Xg |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-07-27 |
| Summary: | summary |